CASI-Plus mHealth for Ukraine's APS Program (Aim 2)

NCT05826977 | Completed DMC

• 2 other identifiers: STUDY000158081R21EB032229-01A1
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

Brief Summary

The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing as part of assisted partner services (APS) in Ukraine, through a mHealth client engagement tool using computer-assisted self-interview (CASI). APS is a strategy for contact tracing and HIV testing for the high-risk sexual and needle-sharing partners of patients known to be living with HIV. This implementation science research will provide useful evidence on whether CASI-Plus can improve partner elicitation and HIV testing in a routine APS program operating at scale, toward the ultimate goal of linkage to HIV prevention and treatment services among those at highest risk of HIV. The aim of the study is to assess adoption of CASI-Plus and its impact on contact elicitation in a randomized controlled trial (RCT). Participants will integrate CASI-Plus as part of the APS services workflow to collect information from clients on sexual partners, needle-sharing partners, and biological children with risk of HIV exposure, and on self-reported partner notification and partner HIV testing outcomes. The investigators will compare APS clients using CASI-Plus to APS clients receiving standard APS services, to see if the contact index (number of partners named per index client enrolled in APS services) and the HIV testing index (number of partners with unknown HIV status tested per index client enrolled in APS services) increase with use of CASI-Plus.

Conditions

HIV Infections

Keywords

Ukraine; HIV testing; partner notification

Outcome Measures

Primary Outcomes (2)

• Contact index

  This is the primary outcome for the R21 study, measured during the initial APS encounter, at client enrollment into the study. Number of partners named per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV management information system (MIS) electronic health record system.

  Baseline measurement

• Testing index

  This is a secondary outcome for the Aim 2 Study. Number of partners with unknown HIV status tested per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV MIS electronic health record system.

  Measured at 8 weeks

Secondary Outcomes (3)

• CASI-Plus tool system usability

  Measured at study completion, on average after 8-12 weeks

• Adoption of CASI-Plus

  Measured between baseline and 8 weeks

• Level of engagement with CASI-Plus

  Measured between baseline and 8 weeks

Study Arms (2)

CASI-Plus

EXPERIMENTAL

The CASI-Plus arm involves use of a tablet-based computerized self-interview tool. This mHealth tool supports the initial assisted partner services (APS) encounter (providing information on how APS works, eliciting names of all sexual or injection partners, screening for risk of intimate partner violence \[IPV\], and planning for partner notification), and facilitates case management through partner testing (via repeat follow-up surveys to assess for barriers to notification, interest in provider assistance, IPV, and completion of notification).

Behavioral: CASI-Plus

Standard of care

NO INTERVENTION

Standard APS services involve: 1\) Nurses, social workers or doctors introduce APS services to clients during routine health care visits and complete partner elicitation and intimate partner violence (IPV) screening via in-person counseling. 3\) HWs discuss options for partner notification. 4) If index clients opts for a HW to notify the partner, the HW makes multiple contact attempts to contact partners by phone. When index clients return for their regular healthcare services, HW follow up with index clients to check if exposed partners have completed the testing process. 5\) If partners have an unknown HIV status, they are encouraged to complete HIV testing. 6\) Partners who test negative for HIV are referred to HIV prevention services, while those with confirmed HIV diagnoses are linked to HIV care and treatment.

Interventions

CASI-Plus BEHAVIORAL

See arm description

CASI-Plus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consent to participate in APS services and the study;
• are 18 years or older;
• have been diagnosed with HIV and enrolled in care;
• have not previously participated in APS services at another health facility; and
• have access to a personal cell phone and internet.

Sponsors & Collaborators

• University of Washington: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Public Health Center, Ministry of Health, Ukraine: collaborator

Study Sites (2)

• Municipal Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council "Center for HIV/AIDS and Hepatitis Prevention"

Chernihiv, Chernihiv Oblast, Ukraine

Location

• Municipal Enterprise "Dnipropetrovsk Regional Medical Center for Socially Significant Diseases" of the Dnipropetrovsk Regional Council

Dnipro, Dnipro, Ukraine

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nancy Puttkammer, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

Model Details: In the R21 trial, in one high-volume health facility, researchers will randomize PLWH (N=178) to either the CASI-Plus or standard care (SC) APS workflow, and measure the use of the tool and contact index using routinely-collected data.

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: August 7, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The HIV MIS and APS register data are considered to be owned by the Ukraine Ministry of Health's Public Health Center (PHC). The Principal Investigator (PI) will share the secondary data obtained for the study from PHC's routine data systems with other researchers, upon written documentation of PHC agreement.

Locations

UA (2)